Intrathecal injection of mesenchymal stem cells (MSC) and repetitive pulsed magnetic stimulation (rTMS) in patients with Alzheimer's disease: a phase I clinical trial
Evaluation of the safety and feasibility of mesenchymal stem cell administration in combination with repetitive transcranial magnetic stimulation for people with Alzheimer's disease
Design
Clinical trial without control group, phase 1 on 15 patients in one group as before and after study
Settings and conduct
At Besat Hospital, patients with Alzheimer's disease will receive intrathecal mesenchymal stem cell injections and a series of repetitive transcranial magnetic stimulation sessions targeting specific brain regions associated with cognitive function. Patients will be enrolled in the study as a single group and compared to before the intervention. Therefore, blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age 50–85 years
2. Meet criteria for probable Alzheimer's disease (AD) according to the National Institute on Aging-Alzheimer's Association (NIA-AA)
3. a score of 18–26 on the Mini-Mental Examination (MMSE)
4. confirmed neurodegeneration due to atrophy on structural brain MRI.
Exclusion criteria:
(1) neurodegenerative diseases other than AD
(2) severe FLAIR white matter enhancement on MRI at baseline, defined as a cap or band (periventricular white matter enhancement) ≥ 10 mm and deep white matter lesions ≥ 25 mm (based on the modified Fazekas ischemia criteria);
(3) major psychiatric disorders;
(4) History of stroke within 3 months of study entry;
(5) Active hepatic, renal, hematological, or pulmonary disorders.
(6) history of malignancy;
(7) Intrathecal injection is difficult or contraindicated.
Intervention groups
Alzheimer's disease patients referred to Be'sat Hospital will undergo intrathecal injection of mesenchymal stem cell and 40 sessions of repetitive transcranial magnetic stimulation (over 8 weeks) .
Main outcome variables
Montreal Cognitive Assessment Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250310065011N1
Registration date:2025-04-17, 1404/01/28
Registration timing:prospective
Last update:2025-04-17, 1404/01/28
Update count:0
Registration date
2025-04-17, 1404/01/28
Registrant information
Name
Kamyab Alizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3995 4956
Email address
ebnesinajournal@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2026-05-22, 1405/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intrathecal injection of mesenchymal stem cells (MSC) and repetitive pulsed magnetic stimulation (rTMS) in patients with Alzheimer's disease: a phase I clinical trial
Public title
Treatment of Alzheimer's disease with mesenchymal stem cells and repetitive pulsed magnetic stimulation (rTMS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50 to 85 years
Meets criteria for probable Alzheimer's disease dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group
Scored 18-26 on the Mini-Mental State Examination (MMSE) screening
Eligible patients will then be screened with MRI imaging and will be enrolled in the study once neurodegeneration due to atrophy is confirmed on structural brain MRI
Exclusion criteria:
(1) have neurodegenerative diseases other than Alzheimer's disease
have severe FLAIR white matter enhancement on MRI at baseline, defined as a cap or band (periventricular white matter enhancement) ≥ 10 mm and deep white matter lesions ≥ 25 mm (based on the modified Fazekas ischemia criteria);
have major psychiatric disorders;
History of stroke within 3 months of study entry;
Active hepatic, renal, hematological, or pulmonary disorders.
Current or prior history of malignancy;
Intrathecal injection is difficult or contraindicated for the patient.
Age
From 50 years old to 85 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of AJA University of Medical Sciences
Street address
Etemadzadeh st, Fatemi gharbi st, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2025-03-01, 1403/12/11
Ethics committee reference number
IR.AJAUMS.REC.1403.292
Health conditions studied
1
Description of health condition studied
Alzheimer's disease
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
Montreal Cognitive Assessment Score
Timepoint
At the beginning of the study (before the intervention) and after the last repetitive pulsed magnetic stimulation session
Method of measurement
The MOCA (Montreal Cognitive Assessment) is a psychological tool designed to assess cognitive functions in adults and consists of 30 questions that take approximately 10 to 15 minutes to complete. The test is divided into several sections: attention and concentration (number repetition and naming), short-term memory (word recall), language (describing objects), visual and spatial abilities (copying geometric shapes), as well as executive function and long-term memory. The total score for the test can range from 0 to 30, with a score above 26 considered normal functioning, 18 to 25 indicating mild cognitive impairment, and below 18 indicating moderate or severe cognitive impairment.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Alzheimer's patients will receive intrathecal mesenchymal stem cells injections (1 × 10^6 cells per kilogram) (Prepared in one of the specialized stem cell centers in Iran) and then a series of repetitive pulsed magnetic stimulation (40 sessions, 5 days per week, 20 Hertz , 30 pulses per train) (Using devices available in the Iranian market) targeting specific brain regions associated with cognitive function.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Yousef Karimi's private clinic
Full name of responsible person
Dr. Yousef Karimi
Street address
No. 288,Piroozi st
City
Tehran
Province
Tehran
Postal code
1781997511
Phone
+98 21 7798 2349
Email
ymkarimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Reza Mosaed
Street address
Aja University of Medical Sciences- Shahid Etemadzadeh Street -West Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
info@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?